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Data / Medical devices / Intervertebral Fusion Device With Bone Graft, Cervical / United States

FDA-registered makers of Intervertebral Fusion Device With Bone Graft, Cervical in the United States: 217 establishments

217 establishments in the United States are registered with the FDA to make Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP). 93 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device
Intervertebral Fusion Device With Bone Graft, Cervical
Product code
ODP
Country
United States

Makers of Intervertebral Fusion Device With Bone Graft, Cervical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer12August 16, 2019000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer12July 11, 2023000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer11July 11, 2023000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer10August 31, 2021010api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer8April 25, 2023000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer8January 12, 2023000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler8August 16, 2019000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer8January 27, 2022010api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer7July 7, 2014000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer7October 30, 2023000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6February 3, 2023000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer6February 14, 2023000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer5December 22, 2020000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer5July 11, 2023000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer5May 19, 2023000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Specification developer5June 6, 2023000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesComplaint file establishment, Manufacturer, Specification developer4February 14, 2023000api.fda.gov
Nanovis Spine, LLCColumbia City, IN, United StatesComplaint file establishment, Manufacturer, Specification developer4June 2, 2023000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer4July 5, 2023000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer4August 16, 2019000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer3January 5, 2023000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer3July 3, 2025000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer3July 3, 2025000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Manufacturer, Specification developer3November 7, 2017000api.fda.gov
CAPTIVA SPINE, Inc.Jupiter, FL, United StatesComplaint file establishment, Specification developer3September 19, 2018000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesManufacturer3January 15, 2026000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer3October 17, 2023000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer3December 22, 2016000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer3October 1, 2014000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer3November 24, 2025000api.fda.gov
Spinecraft LLCWestmont, IL, United StatesManufacturer, Specification developer3April 16, 2026000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer3March 2, 2016000api.fda.gov
Xenco Medical LLCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3December 11, 2015000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Specification developer3September 1, 2023000api.fda.gov
Zsfab IncWaltham, MA, United StatesComplaint file establishment, Specification developer3November 7, 2024000api.fda.gov
Acuity Surgical Devices, LLCIrving, TX, United StatesManufacturer, Repackager or relabeler2December 1, 2023000api.fda.gov
Additive ImplantsPhoenix, AZ, United StatesSpecification developer2January 3, 2020000api.fda.gov
Atlas Spine Inc.Jupiter, FL, United StatesManufacturer2June 13, 2018000api.fda.gov
Aurora Spine, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2August 2, 2021000api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Specification developer2February 27, 2018000api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer2January 6, 2026000api.fda.gov
Cutting Edge SpineMineral Spgs, NC, United StatesRepackager or relabeler, Specification developer2March 12, 2025000api.fda.gov
Degen MedicalFlorence, SC, United StatesComplaint file establishment, Specification developer2October 10, 2025000api.fda.gov
G Surgical LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Specification developer2April 23, 2021000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer2September 3, 2015000api.fda.gov
Met One Technologies, LLCEl Paso, TX, United StatesManufacturer, Specification developer2December 22, 2022000api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer2June 11, 2020000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer2August 22, 2017000api.fda.gov
NanoHive Medical LLCWoburn, MA, United StatesManufacturer, Specification developer2February 13, 2026000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer2October 20, 2014000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2December 21, 2017000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2December 21, 2017000api.fda.gov
Ulrich Medical Usa, Inc.Plano, TX, United StatesSpecification developer2May 23, 2024000api.fda.gov
Altus PartnersWest Chester, PA, United StatesSpecification developer1November 21, 2017000api.fda.gov
ARCH Medical Solutions - Escondido LLCEscondido, CA, United StatesManufacturer1May 13, 2016000api.fda.gov
Addivation MedicalReno, NV, United StatesSpecification developer1July 30, 2019000api.fda.gov
CPM Medical Consultants, LLC.Farmers Branch, TX, United StatesComplaint file establishment, Specification developer1February 7, 2013000api.fda.gov
Demetra, Inc.Germantown, TN, United StatesComplaint file establishment, Specification developer1December 28, 2020000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer1October 15, 2022000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesComplaint file establishment, Specification developer1October 15, 2022000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1November 2, 2009000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer1February 6, 2023000api.fda.gov
Evolution Spine, LLCDallas, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1May 5, 2016000api.fda.gov
Flospine LLCBoca Raton, FL, United StatesManufacturer1February 24, 2023000api.fda.gov
Happe SpineGrand Rapids, MI, United StatesComplaint file establishment, Specification developer1April 28, 2023000api.fda.gov
HAPPE SpineAuburn, IN, United StatesManufacturer1April 28, 2023000api.fda.gov
HC Biologics LLCMiami, FL, United StatesManufacturer1April 13, 2026000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1August 24, 2021000api.fda.gov
Integrity SpineSan Antonio, TX, United StatesManufacturer1November 18, 2013000api.fda.gov
K7 LLCHenderson, NV, United StatesManufacturer, Specification developer1January 4, 2013000api.fda.gov
KeosNaples, FL, United StatesSpecification developer1June 6, 2022000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1April 16, 2014000api.fda.gov
Medynus, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1September 23, 2021000api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer1March 12, 2024000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesComplaint file establishment, Specification developer1March 12, 2024000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer1June 12, 2013000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer1July 3, 2017000api.fda.gov
Osteomni IncMiami, FL, United StatesSpecification developer1May 12, 2026000api.fda.gov
Providence Medical Technology, Inc.Pleasanton, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1May 24, 2013000api.fda.gov
Pantheon Spinal LLCGeorgetown, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1June 20, 2017000api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesContract manufacturer, Manufacturer1October 13, 2010000api.fda.gov
Republic SpineFort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer1June 19, 2019000api.fda.gov
Rhausler, Inc.Fremont, CA, United StatesSpecification developer1November 19, 2015000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1January 27, 2010000api.fda.gov
Southern Spine, LLCMacon, GA, United StatesSpecification developer1August 14, 2013000api.fda.gov
Spectrum Spine IncJasper, GA, United StatesManufacturer1May 30, 2024000api.fda.gov
SpineNet LLCMaitland, FL, United StatesSpecification developer1August 25, 2011010api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1February 7, 2008000api.fda.gov
The Orthopaedic Implant CompanyReno, NV, United StatesSpecification developer1January 27, 2010000api.fda.gov
Valorus Spine, LLCDanville, CA, United StatesManufacturer1February 26, 2018000api.fda.gov
Wenzel SpineAustin, TX, United StatesSpecification developer1September 27, 2023000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesContract manufacturer, Manufacturer1November 23, 2011000api.fda.gov
restor3d, inc.Durham, NC, United StatesManufacturer1October 24, 2019000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
Ar FabricatingGeorgetown, TX, United StatesContract manufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical ComponentsHuntingdon Valley, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - ElmhurstElmhurst, IL, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Armadillo Additive, Inc.Granbury, TX, United StatesContract manufacturer0000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Blustone Synergy, LLCPueblo, CO, United StatesSpecification developer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
Calvary Spine, LLCTowson, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Design And Services Hub, LLCHartville, OH, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Elevation SpineMonterey, CA, United StatesSpecification developer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations Inc.Spartanburg, SC, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isotis Orthobiologics, IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Linear Precision, Inc.Florence, SC, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Machining Midtown LLCAtlanta, GA, United StatesContract manufacturer0000api.fda.gov
Medicraft IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
NML Medical, LLCWest Carrollton, OH, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Oaktree AdditiveTampa, FL, United StatesContract manufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Pro Surgical, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PT Solutions, LLCBrunswick, OH, United StatesContract manufacturer0000api.fda.gov
Pulse Technologies, Inc.Quakertown, PA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer0010api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Revelation Medical Devices, LLCAuburn, IN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Romd, LLCRochester Hills, MI, United StatesContract manufacturer0000api.fda.gov
SINTX Technologies Inc.Salt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Spineup IncMiami, FL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Sites Medical, LLCColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Sterigenics U.S., LLCCorona, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Troy Innovative Instruments Co LLCMiddlefield, OH, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Xcix Design, LLCRichmond, UT, United StatesContract manufacturer0000api.fda.gov
Xyresic LLCJackson, MI, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.